Using psilocybin to treat depression in adults with cancer

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of up to Two Doses of Psilocybin for the Treatment of Major Depressive Disorder in Adults With Cancer

This study is testing if a special treatment using psilocybin can help adults with cancer and depression feel better.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 56 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Sunstone Medical (Academic / other)
• Drugs / interventions: chemotherapy, radiation
• Locations: 1 site (Rockville, Maryland)
• Trial ID: NCT05947383 on ClinicalTrials.gov

What this trial studies

This Phase 2 clinical trial investigates the efficacy, safety, and tolerability of two doses of psilocybin in adults diagnosed with Major Depressive Disorder (MDD) who also have cancer. Participants will receive a fixed dose of 25 mg of psilocybin in a double-blind, randomized, placebo-controlled setting during the first dosing session, followed by an open-label session for those who do not achieve remission. The study aims to assess the impact of psilocybin on depressive symptoms while providing therapeutic support through dedicated therapists. The trial is conducted at a single center in Rockville, Maryland.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with a diagnosis of Major Depressive Disorder and a malignant neoplasm.

Not a fit: Patients with a history of schizophrenia, psychotic disorders, or those currently on antidepressant or antipsychotic medications may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly alleviate depressive symptoms in cancer patients, improving their overall quality of life.

How similar studies have performed: Previous studies have shown promising results with psilocybin for treating depression, indicating potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

1. Signed informed consent form (ICF)
2. 18 years of age or above at Screening (V1)
3. Currently meet criteria for MDD (single or recurrent episode as defined by the DSM-5; if single episode, duration of ≥ 3 months) based on medical records, clinical assessment, and documented completion of the Mini International Neuropsychiatric Interview, version 7.0.2 (MINI 7.0.2)
4. A diagnosis of a malignant neoplasm with a diagnostic code from C00 to C97 according to the ICD-10
5. MADRS score ≥ 20 at Screening (V1)
6. Is not currently taking any antidepressant and/or antipsychotic medications or medical cannabis at Screening (V1)
7. Able to complete all protocol-required assessment tools without any assistance or alteration to the copyrighted assessments, and to comply with all study visits
8. Has capacity to consent per judgement of the Investigator

Exclusion Criteria:

1. Current or past history of schizophrenia, psychotic disorder, bipolar disorder, delusional disorder, paranoid personality disorder, schizoaffective disorder, or borderline personality disorder, as assessed by medical history and a structured clinical interview (MINI version 7.0.2)
2. Current (within the past year) alcohol or drug use disorder as defined by the DSM-5 (MINI 7.0.2) at Screening (V1)
3. Significant suicide risk defined by (1) suicidal ideation as endorsed on items 4 or 5 on the C-SSRS within the past year, at Screening, or at Baseline, or; (2) suicidal behaviors within the past year, or; (3) clinical assessment of significant suicidal risk during participant interview
4. Other personal circumstances or behavior judged to be incompatible with establishment of rapport or safe exposure to psilocybin
5. Women who are pregnant, nursing, or planning a pregnancy. Women and men of child-bearing potential and who are sexually active must agree to use an acceptable contraceptive method throughout their participation in the study. Women of child-bearing potential must have a negative urine pregnancy test at Screening (V1) and Baseline (V2)
6. Cardiovascular conditions: recent stroke (\< 1 year from signing of ICF), recent myocardial infarction (\< 1 year from signing of ICF), uncontrolled hypertension (blood pressure \> 140/90), or clinically significant arrhythmia within 1 year of signing the ICF
7. A marked prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval \> 450 ms at screening
8. A history of additional risk factors for Torsade de Pointes (e.g., heart failure, hypokalemia, family history of long QT syndrome)
9. The use of concomitant medications that prolong the QT/QTc interval
10. Uncontrolled or insulin-dependent diabetes
11. Seizure disorder
12. Positive urine drug screen for illicit drugs or drugs of abuse at V1 and V2. Any positive urine drug test will be reviewed with participants to determine the pattern of use and eligibility will be determined at the Investigator's discretion in conjunction with the medical monitor
13. Current enrollment in any investigational drug or device study or participation in such within 30 days of Screening (V1)
14. Abnormal and clinically significant results on the physical examination, vital signs, ECG, or laboratory tests at Screening (V1) that in the Investigator's opinion may constitute a risk for an individual who is exposed to psilocybin. This includes a value of \< 50,000 platelets per cubic millimeter of blood, liver function tests three times the upper limit of normal, and creatine two times above the normal range. Clinically significant abnormal electrolytes or low hemoglobin (\< 8 g/L) should be corrected and rechecked prior to enrollment
15. Any other clinically significant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, or any other major concurrent illness that, in the opinion of the Investigator, may interfere with the interpretation of the study results or constitute a health risk for the participant if they take part in the study
16. Use of psychedelics, including psilocybin but excluding medical marijuana, within the past 6 months and use of psychedelics or cannabis during the current episode of depression
17. Concurrent or recent chemotherapy or radiation therapy that impairs general level of physical functioning

Where this trial is running

Rockville, Maryland

• Sunstone Medical, PC — Rockville, Maryland, United States (Recruiting)

Study contacts

• Study coordinator: Study Contact

Conditions Cancer; Major Depressive Disorder; psilocybin; cancer; depression